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Jazz Pharmaceuticals was involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Yves Dauvilliers is a consultant for and has participated in advisory boards for Jazz Pharmaceuticals, UCB Pharma, Flamel Technologies, Idorsia, Takeda, Theranexus, and Bioprojet. Karel \u0160onka has served on the speakers\u2019 bureau for Sanofi, Angelini, and Stada and participated in advisory boards for UCB and in clinical trials for Jazz Pharmaceuticals, Flamel-Avadel, and Luitpold Pharmaceuticals. Richard K. Bogan is a shareholder of WaterMark Medical and Healthy Humming, LLC; is on the board of directors of WaterMark Medical; serves as a consultant to Jazz Pharmaceuticals, Harmony Biosciences, Avadel Pharmaceuticals, Takeda, and Oventus; conducts industry-funded research for Avadel Pharmaceuticals, Axsome Therapeutics, Bresotec Medical, Bayer, Idorsia, Suven Life Sciences, Jazz Pharmaceuticals, Balance Pharma Inc., NLS Pharmaceutics, Vanda Pharmaceuticals Inc., Merck, Eisai Co. Ltd, Philips, Fresca Medical, Takeda, LivaNova, Roche, Sanofi, Sommetrics, and Noctrix Health; and has served on the speakers\u2019 bureau for Jazz Pharmaceuticals, Eisai Co. Ltd., and Harmony Biosciences. Markku Partinen has participated in advisory boards of AOP Orphan, Bioprojet, UCB, and Umecrine. He has participated in clinical trials for Bioprojet, Jazz Pharmaceuticals, MSD, and Umecrine. Rafael del Rio Villegas has participated in advisory boards for Bioprojet and trials for Jazz Pharmaceuticals, Bioprojet, and Takeda. Nancy Foldvary-Schaefer served as a consultant for Jazz Pharmaceuticals and receives research support from Jazz Pharmaceuticals, Suven Life Sciences, and Takeda Pharmaceuticals. Roman Skowronski is a full-time employee of Jazz Pharmaceuticals who, in the course of this employment, has received stock options exercisable for, and other stock awards of, ordinary shares of Jazz Pharmaceuticals, plc. Abby Chen is a full-time employee of Jazz Pharmaceuticals who, in the course of this employment, has received stock options exercisable for, and other stock awards of, ordinary shares of Jazz Pharmaceuticals, plc. Jed Black is a part-time employee of Jazz Pharmaceuticals and shareholder of Jazz Pharmaceuticals plc. Franck Skobieranda is a full-time employee of Jazz Pharmaceuticals and shareholder of Jazz Pharmaceuticals, plc. Michael J. Thorpy has received research\/grant support and consultancy fees from Jazz Pharmaceuticals, Harmony Biosciences, Balance Therapeutics, Axsome Therapeutics, and Avadel Pharmaceuticals.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study was approved by institutional review boards or ethics committees at all sites and was performed in accordance with the International Conference on Harmonisation Guideline for Good Clinical Practice and the Declaration of Helsinki.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All participants provided written informed consent.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publish"}},{"value":"All relevant data are provided within the manuscript and supporting files.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"All authors had full access to all the data in the study and take full responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: RS and YD. Acquisition, analysis, or interpretation of data: YD, KS, RKB, MP, RdRV, NF-S, RS, AC, JB, FS, MJT. Drafting of the manuscript: Under the direction of the authors, Karyn Liu, PhD, and Michael J. Theisen, PhD, of Peloton Advantage, LLC, an OPEN Health company, provided medical writing assistance for this publication. Critical revision of the manuscript for important intellectual content: YD, KS, RKB, MP, RdRV, NF-S, RS, AC, JB, FS, MJT. Statistical analysis: AC. Obtaining funding: Funded by Jazz Pharmaceuticals. Administrative, technical, or material support: Peloton Advantage, LLC, an OPEN Health company. Study supervision: RKB, RS.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}